MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293071230
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an innova self-expanding stent delivery system (sds) with a.018 guidewire inside of the device.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.There was a.018 guidewire in the lumen of the device that was protruding out from the tip approximately 18cm.The wire was sticking out of the proximal end approximately 122cm.The guidewire was pulled out of the device with no effort.The pull handle was completely pulled to its complete travel.The stent was not returned.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
Same case as mdr 2134265-2017-05649.It was reported that the delivery system was stuck on the wire.A 7 x 120 x 130 innova¿ stent was selected for a left superficial femoral artery (sfa) angioplasty and stent placement procedure.After normal stent deployment, during removal of the stent delivery system, the stent delivery system became jammed on the v-18 control wire.The guidewire and the stent delivery system had to be removed together.There were no patient complications.The patient's status was reported as fine.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6591777
• Report Number: 2134265-2017-04833
• Device Sequence Number: 105971
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: (01)08714729874126(17)20190630(10)19377504
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: H74939293071230
• Device Catalogue Number: 39293-07123
• Device Lot Number: 19377504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR