MAUDE Adverse Event Report: EMBOLX, INC. SNIPER; BALLOON OCCLUSION CATHETER

Model Number	SBC0629-KTP-150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
With the distal tip blocked, the catheter was pressurized with 100% contrast.The fluid began to leak out of the shaft at the distal shaft kink location and back through the guidewire lumen and into the hub.This indicates that the outer shaft is punctured, and the inflation/deflation channel communicates with the guidewire lumen.The puncture likely prevented the balloon from deflating as deflation vacuum could have been drawn into the guidewire lumen through the hub.There is no leak between the lumens in the hub itself.The hole in the catheter shaft distally could be the reason the balloon would not deflate.It is unknown how or when these kinks occurred.Device prep sequence should identify leaks and shaft kinks before use.
Event or Problem Description
Balloon would not deflate.

• Brand Name: SNIPER
• Common Device Name: BALLOON OCCLUSION CATHETER
• Manufacturer (Section D): EMBOLX, INC.; 530 lakeside drive, #200; sunnyvale, ca
• MDR Report Key: 10176840
• Report Number: 3011660785-2020-00003
• Device Sequence Number: 11420664
• Product Code: MJN
• UDI-Device Identifier: 00853359008087
• UDI-Public: (01)00853359008087(17)210408(10)EMB04082001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2020

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: 04/08/2021
• Device Model Number: SBC0629-KTP-150
• Device Catalogue Number: SBC0629-KTP-150
• Device Lot Number: EMB040820-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR