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

Catalog Number PCE060080090

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used pacific plus pta balloon during procedure to treat an unknown vessel.Balloon deflation difficulties occurred, device would not deflate at the lesion site.It was reported that the device did not fully deflate, when the half-deflated balloon was pulled out with more force, the catheter got torn off.The balloon was stuck in the sheath and could be recovered fully.The catheter tore at the shaft due to removal difficulties during device withdrawal.There was no patient injury reported.

Manufacturer Narrative

Device evaluation: the pacific plus catheter was received locked up on a 0.018¿ compatible guidewire and stuck at the distal end of a 4fr support sheath.The lot number information printed on the y-manifold was consistent with the data on a peel-off label and the reported event.The pacific plus catheter was gently advanced distally out of the 4fr support sheath.The balloon chamber material was bunched up at the distal end of the 4fr sheath.The balloon chamber material that was previously within the 4fr sheath was tightly twisted.Sanguine residue was within the balloon chamber indicating communication between the balloon chamber and the sanguine environment, (e.G.Leak).The pacific plus catheter proximal to the balloon chamber was necked down and elongated.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

Additional information: no damage noted to packaging prior to use.No issues noted during preparation of the device.Lesion pre-dilation was not performed.The balloon was not passed through a previously deployed stent.No resistance was noted during advancement of the device.It is reported the balloon was deflated correctly according to ifu but could not be retracted from the patient¿s vessel.Firm force was used when trying to remove the balloon and it became stuck in the sheath.The balloon particles and the sheath were removed from the patient immediately.A control radioscopy was completed to ensure no device fragments were left in the patient.The procedure was completed at this point.The patient is reported to be doing well.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

Additional information: there was a deflation issue.The balloon could not be fully deflated and therefore retraction was so difficult.The particles of the balloon were all caught in the sheath, so with the removal of the sheath, everything could be retracted from the patient.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: 9564177
• MDR Text Key: 198594942
• Report Number: 3004066202-2020-00001
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: PCE060080090
• Device Lot Number: 1M000862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/09/2020; 01/09/2020; 03/04/2020
• Supplement Dates FDA Received: 01/09/2020; 01/09/2020; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1