MAUDE Adverse Event Report: INVATEC SPA PACIFIC PLUS; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PCE060040090

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915)

Patient Problem Pain (1994)

Event Date 03/23/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a pacific xtreme device with a non-medtronic 5f sheath and non-medtronic guidewire during treatment of a lesion in the patient¿s distal left superficial femoral artery (sfa).Lesion exhibited 90% stenosis.Ifu was followed and the device was prepped without issue.Three successful dilations of in stent restenosis were performed with the pacific xtreme balloon.The inflation pressure of the balloon was maintained below rbp.The balloon was completely deflated for removal from the patient without reported issue.When the physician was withdrawing the balloon through the introducer sheath some resistance was noted.The physician injected some contrast and the balloon was further withdrawn and a sudden loss in resistance was noted.The patient then complained about pain in the malleolar region.The balloon is reported to have ruptured and the shaft could not be retrieved on the non-medtronic wire.Angiography showed the balloon outside of the introducer sheath (both markers visible).When the physician pulled back the wire, only the distal marker was observed to have moved into the sheath.The physician then decided to remove the balloon, wire and sheath in tandem, while attempting to keep the detached balloon portion also.Only the distal marker was removed.A 7fr sheath was placed and dilation was performed to reduce resistance using another pacific xtreme device.The balloon fragment continued to migrate distally and became wedged in the stent.The pacific xtreme was placed dismally and partially inflated to pull up the detached balloon piece up close to the sheath.The pacific xtreme was then deflated completely and removed without issue.The physician then advanced a gooseneck snare to try and retrieve the balloon portion unsuccessfully.The guidewire tip is reported to have broken and became caught on the stent but was removed with a gooseneck snare.The guidewire removal attempt caused the damage to the stent resulting in it ¿unknotting¿.An attempt was made to catch the detached piece of balloon with the snare but was unsuccessful.Additional efforts were made to remove the balloon fragment but these were unsuccessful and resulted in stent fracture.The patient was sent to bypass surgery.No further injury reported.

Manufacturer Narrative

The pacific xtreme balloon was used to treat an in stent restenosis of a non-medtronic stents.There was no vessel damage noted.The surgery went well, the bypass is patent and the patient is doing fine.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: originally reported device as pacific xtreme in b5.This should have stated pacific plus.510(k)# corrected to k123358 image review: four photographs of cine images were received.Cropped enlargements were made to aid in the technical analysis of the images.The first image appears to be a contrast flow of the targeted vessel anatomy; the patient¿s distal left superficial femoral artery (sfa).Three lesions appear to exhibit a high percentage of stenosis in the artery.The lesions are within previously implanted stents.In the second image a pta balloon catheter is inflated in the stent closest to the knee.The stents appear nominal; no abnormality nor deformity.The pta balloon catheter is on a guidewire in the image.In the third image a pta balloon catheter is inflated in the distal end of the proximal stent and the proximal end of the distal stent.The pta balloon catheter is on a guidewire.The proximal end of the proximal stent appears nominal.There appears to be a second guidewire running along the outside of the balloon chamber that is visible both proximal and distal of the inflated balloon chamber.In the fourth image the proximal end of the stent appea rs to be entangled in a guidewire.The proximal end of the proximal stent exhibits stent cell row elongation and fracture.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: four photographs of cine images were received.Cropped enlargements were made to aid in the technical analysis of the images.The first image appears to be a contrast flow of the targeted vessel anatomy; the patient¿s distal left superficial femoral artery (sfa).Three lesions appears to exhibited a high percentage of stenosis in the artery.The lesions are within previously implanted stents.In the second image a pta balloon catheter is inflated in the stent closest to the knee, the stents appear nominal; no abnormality nor deformity.The pta balloon catheter is on a guide wire in the image.In the third image a pta balloon catheter is inflated in the distal end of the proximal stent and the proximal end of the distal stent.The pta balloon catheter is on a guide wire.The proximal end of the proximal stent appears nominal.There appears to be a second guide wire running along the outside of the balloon chamber that is visible both proximal and distal of the inflated balloon chamber.In the fourth image the proximal end of the stent appears to be entangled in a guide wire.The proximal end of the proximal stent exhibits stent cell row elongation and fracture.Product analysis: the pacific plus pta balloon catheter was returned to medtronic investigation lab for evaluation.The device was received within a s ealed paper envelope, and loosely coiled wrapped up in a surgical drape.No ancillary devices nor procedural images were received for evaluation.Only the manifold and catheter section of the pacific plus pta balloon catheter were returned for evaluation.The separation face is in the area of the balloon proximal bond.The proximal bond material on the catheter exhibits a diagonal ragged tear separation face.The balloon chamber, inner guide wire lumen, two radiopaque marker bands, and the distal tip were not returned with the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC PLUS
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• MDR Report Key: 9877771
• MDR Text Key: 195741063
• Report Number: 3004066202-2020-00014
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K123358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2022
• Device Catalogue Number: PCE060040090
• Device Lot Number: 1M003362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention