MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number SBI06015008S

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

Patient Problem Intimal Dissection (1333)

Event Date 03/26/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use an inpact admiral during treatment of the patient¿s mid superficial femoral artery (sfa).Slight vessel tortuosity is reported.The lesion was calcified.A non medtronic inflation device was used for balloon inflation.A 6fr 11cm non-medtronic sheath was used.No issue was noted with the product packaging.No issues were noted when the device was removed from the product packaging.Ifu was followed.No resistance was noted during advancement of the balloon.The device did not pass through a previously-deployed stent.It is reported removal difficulties were noted when removing the device from the patient post treatment.The balloon was fully deflated during removal and the physician had negative pressure on the balloon to allow removal.No intervention was required for the removal of the device.The remainder of the device was able to be pulled through the non-medtronic sheath.No further treatment required.The device was safely removed from the patient.A stent was required for the lesion after balloon removal due to dissection caused by inpact admiral.No patient injury reported.

Manufacturer Narrative

Additional information: while removing the in.Pact admiral from the patient, separation occurred with no tension having been applied to the device.Procedure was already completed at this time and all parts of the device were retrieved.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the device was received by medtronic for evaluation.The device was decontaminated with cidex-opa and tergazyme soak pending further testing to support the final product analysis findings.The device returned with a detachment on the catheter.The detachment was evident under the strain relief distal to the luer bonding site.The catheter was slightly stretched, jagged and uneven on both sides of the detachment site.The strain relief was damaged at the site of detachment.The balloon appeared to be fully deflated.No other damage was noted to 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: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9938010
• MDR Text Key: 189743295
• Report Number: 9612164-2020-01531
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2022
• Device Catalogue Number: SBI06015008S
• Device Lot Number: 0009547565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 04/05/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 04/29/2020; 08/04/2020
• Supplement Dates FDA Received: 05/01/2020; 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention