MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SPECTRANETICS BRIDGE BALLOON PREP KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	00884450294819
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a successful lead extraction proceudre, the patient was stable and the pocket was closed.When the 12f introducer sheath was removed from the groin after the procedure, bleeding was noticed in the area.Vascular surgeon discovered an injury in the right common iliac artery.The account alleges that the needle contained within the bridge accessory kit punctured both the femoral vein and the artery during preparation for prophylactic staging of the bridge balloon prior to the case, and that the 12f introducer sheath provided tamponade to the injury during the actual procedure.Only after the 12f introducer sheath was removed was the injury detected.It has been reported that the right common iliac artery was stented and the patient survived the procedure.There was no alleged malfunction of the bridge balloon, nor did the bridge balloon itself contribute to a serious injury.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: SPECTRANETICS BRIDGE BALLOON PREP KIT
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10317257
• Report Number: 1721504-2020-00054
• Device Sequence Number: 14084946
• Product Code: OEQ
• UDI-Device Identifier: 00884450294819
• UDI-Public: 00884450294819
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2022
• Device Model Number: 00884450294819
• Device Catalogue Number: K12-09098A
• Device Lot Number: H1707295
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention