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

Catalog Number ADM06015008P

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the inpact admiral drug eluting balloon was used for the lesion of the superficial femoral artery.The wire metal was found from in.Pact admiral as well on the catheter room on the previous day, and dr.(b)(6) was visited.The physician did not have a scene that the wire metal came out from in.Pact admiral during the procedure, and the report was received from clinical engineer (ce), so details was requested to be confirmed with ce.The physician did not notice strangeness during the procedure.Regarding for this case, it could not be confirmed that the wire was coming out from in.Pact admiral, but a similar wire came from in.Pact admiral in the previous case (it was reported in complant no.(b)(4)), the physician reported that the similar wire was in the sterile field.It had already been confirmed that there was no dependency on the body and patient injury.As mentioned above, it was unable to be clearly identified that the issue was caused by in.Pact admiral, but since similar case occurred at the same facility, a defect report was submitted.The distributor was requested to confirm the possibility that the wire was used for other devices used in the same procedure.No difficulty removing device, no unusual resistance noted when the protective sheath was removed, negative pressure was applied to the device, no abnormalities during the prep, device inspection before use, no abnormalities during device inspection, no resistance with ancillary device during delivery or during passing the lesion site.The device was used without any issues noted.

Manufacturer Narrative

Device evaluation the balloon returned deflated with balloon folds were open, and crystallised residue was visible inside balloon.Resistance was felt while loading a 0.035 inch guidewire through the device due to hardened residue in the guidewire lumen.No other kinks or abnormalities were noted on the device.An unidentified wire with length 35.5cm was returned with the device.The od of the unidentified wire was 0.38 mm.Both ends of the unidentified wire were deburred, indicating that this was not a section of wire that had detached from the device.Technical analysis confirmed that an unidentified wire returned along with the device.It is most likely that the unidentified wire was introduced post release of the device from the manufacturing facility.No manufacturing related or potential manufacturing related root cause was identified image review one photograph was received from the account, capturing the in.Pact admiral device, packaging stylette and unidentified wire.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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8431533
• MDR Text Key: 139167231
• Report Number: 9612164-2019-00923
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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: 01/21/2021
• Device Catalogue Number: ADM06015008P
• Device Lot Number: 0008962606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1