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

Model Number H74939147251510

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that balloon detachment occurred.The target lesion was located in a vessel below the knee.A 2.5mm x 150mm x 150cm sterling¿ sl balloon catheter was advanced for dilatation.The balloon was inflated at nominal pressure and then deflated without problems.However, during withdrawal of the device, it was noted that the holder with the balloon broke and remained inside the patient's body.Subsequently, a lasso was used to retrieve the remaining component and the procedure was terminated.No patient complications were reported and the patient's status was well.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter in two pieces.The balloon was tightly folded with blood in the balloon, inflation lumen and wire lumen.The tip, balloon, inner/outer shaft, port/exit notch, and hypotube were microscopically and tactile inspected.Inspection revealed a complete separation of the shaft (located 25cm from the tip of the device) and hypotube, numerous kinks in the hypotube and distal outer, and inner shaft damage (buckling located 140mm from the tip of the device).There was numerous kinks and damage that was consistent with excessive tensile force at the site of the separation.The fracture faces of the hypotube were oval, as if kinked prior to separation.Inspection of the remainder of the device revealed no other damage or irregularities.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 balloon detachment occurred.The target lesion was located in a vessel below the knee.A 2.5mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.The balloon was inflated at nominal pressure and then deflated without problems.However, during withdrawal of the device, it was noted that the holder with the balloon broke and remained inside the patient's body.Subsequently, a lasso was used to retrieve the remaining component and the procedure was terminated.No patient complications were reported and the patient's status was well.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6849196
• MDR Text Key: 85151365
• Report Number: 2134265-2017-08646
• 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,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2019
• Device Model Number: H74939147251510
• Device Catalogue Number: 39147-25151
• Device Lot Number: 20738780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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