MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number H74939032302290

Device Problem Break (1069)

Patient Problem Blood Loss (2597)

Event Date 06/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that shaft break occurred and patient had significant bleeding.The target lesion was located in the occluded and moderately calcified anterior tibial artery.A 3.0x220x90 (4f) sterling¿ balloon catheter was advanced for dilatation and it was noted that the shaft was broken.The broken piece was recovered; however, the patient experienced significant bleeding.All the hardware was removed and compression was performed to stop the bleeding.It was noted that the guide wire was too thin and it was not possible to return the introducer sheath which caused the bleeding and the procedure was stopped.No further patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a sterling balloon catheter without the distal inner and the distal portion of the balloon.There is blood in the inflation lumen and balloon.The outer shaft, inner shaft, balloon and tip were microscopically examined.The balloon is completely circumferential torn off 11 mm from the proximal balloon cone.The distal balloon and tip were not returned.The balloon also has an 11 mm longitudinal tear starting at the proximal balloon cone.The inner shaft was completely separated 63.8 cm from the strain relief.The fractured/separated end of the inner shaft was stretched and jagged which indicates the shaft separation was due to tensile forces.The distal shaft, distal balloon and tip were not returned for analysis.There was no evidence of any material or manufacturing deficiencies contributing to the damage or the reported difficulty.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that shaft break occurred and patient had significant bleeding.The target lesion was located in the occluded and moderately calcified anterior tibial artery.A 3.0x220x90 (4f) sterling¿ balloon catheter was advanced for dilatation and it was noted that the shaft was broken.The broken piece was recovered; however, the patient experienced significant bleeding.All the hardware was removed and compression was performed to stop the bleeding.It was noted that the guide wire was too thin and it was not possible to return the introducer sheath which caused the bleeding and the procedure was stopped.No further patient complications were reported.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7664586
• MDR Text Key: 113257470
• Report Number: 2134265-2018-05895
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2019
• Device Model Number: H74939032302290
• Device Catalogue Number: 39032-30229
• Device Lot Number: 21914435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention