MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿ SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number H74939147208010

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that shaft break occurred and catheter withdrawal difficulties were encountered.The target lesion was located in an artery in the leg at the level of the ankle.A 20/300 v-18 control wire was advanced to cross the lesion with very strong angulation at the level of the tibioperoneal trunk with the wire forming almost an elbow, a plication.A 2.0mmx80mmx150cm sterling balloon catheter was advanced for dilation.However, when the physician removed the balloon, the balloon shaft tore into pieces because of this plication which did not allow it to slide normally on the guidewire.A piece of the balloon remained in the artery and a small open surgery was performed to remove that piece of the balloon that remained in the artery.No further patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device avail.For eval.Corrected from yes to no.Device returned to mfr.Corrected from yes to no.Method codes, result codes and conclusion codes updated.Device evaluated by mfr.: the device was not returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical/ procedural factors.(b)(4).

Event Description

It was reported that shaft break occurred and catheter withdrawal difficulties were encountered.The target lesion was located in an artery in the leg at the level of the ankle.A 20/300 v-18 control wire was advanced to cross the lesion with very strong angulation at the level of the tibioperoneal trunk with the wire forming almost an elbow, a plication.A 2.0mmx80mmx150cm sterling balloon catheter was advanced for dilation.However, when the physician removed the balloon, the balloon shaft tore into pieces because of this plication which did not allow it to slide normally on the guidewire.A piece of the balloon remained in the artery and a small open surgery was performed to remove that piece of the balloon that remained in the artery.No further patient complications were reported and the patient's status was good.

• Brand Name: STERLING¿ SL
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5508429
• MDR Text Key: 40632106
• Report Number: 2134265-2016-01846
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

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: 10/31/2017
• Device Model Number: H74939147208010
• Device Catalogue Number: 39147-20801
• Device Lot Number: 18559509
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2015
• 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