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

Model Number ADM06004013P

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use an inpact admiral drug-coated balloon with a 6fr non-medtronic sheath and non-medtronic soft guidewire during treatment of a calcified lesion in the patient¿s proximal right superficial femoral artery (sfa).Moderate vessel calcification and tortuosity are reported.Lesion diameter reported as 7mm.No damage noted to the product packaging prior to use.No issues noted when removing the device from the product packaging.Ifu was followed.The physician reported difficulty with 6 french sheath insertion.Physician chose the non-medtronic 6fr sheath for procedure because of this.Atherectomy was performed initially followed by successful use of the inpact admiral balloon.When the physician attempted to remove the inpact admiral, it is reported to have become stuck in the sheath.The shaft of the catheter is reported to have broken during attempted removal.The physician then removed the sheath from the patient with the balloon inside, held pressure on the access site, and used a femstop to continue to hold pressure on the access site.No patient injury reported.

Manufacturer Narrative

Additional information: the physician mentioned that the balloon may not have been fully deflated during removal attempt.It was a complete fracture of the balloon catheter, where the balloon itself is still inside the sheath.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.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

Product analysis: the device was received 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 detachment on catheter.The remaining detached portion of the catheter and balloon was situated within the 6fr guide catheter.A section of the distal tip was exposed distal to tip of guide catheter.Slight damage was evident to the guide catheter tip, and scratches/indentation marks were evident on the guide catheter.Hardened blood/residue was visible within guide catheter surrounding the distal tip.The guide catheter was cut back to expose the remaining detached portion of the catheter and balloon.The catheter material was stretched, jagged and uneven at the detachment site.An attempt was made to remove the remaining portion of the device proximally through the guide catheter however resistance was felt.It was not possible to remove the remaining portion of the device.The guide catheter was further cut back to expose the balloon, and hardened blood and residue was evident surrounding balloon material.Traces of contrast were evident in the distal balloon material.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 CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10199179
• MDR Text Key: 196566364
• Report Number: 9612164-2020-02328
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: 00643169383258
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2020

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: 11/20/2022
• Device Model Number: ADM06004013P
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0010026675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/07/2020; 08/24/2020
• Supplement Dates FDA Received: 07/09/2020; 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 92