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

Model Number H74939148301510

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-00410.It was reported that catheter entrapment occurred.The target lesion was located in a hepatic vessel.A 3.0mm x 150mm x 150cm sterling¿ sl balloon catheter was advanced over a v-18 guide wire for dilatation.The balloon was inflated for one time; however, when the physician changed position for other segment, the balloon did not inflate and became stuck on wire.The device was removed and the procedure was completed with another of the same device.No patient complications were noted and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The inner shaft is buckled in numerous locations.The buckling damage is consistent with the damage that is seen caused by use of a guidewire.The tip is damaged.There are numerous shaft kinks.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The investigation conclusion is caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-00410.It was reported that catheter entrapment occurred.The target lesion was located in a hepatic vessel.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced over a v-18 guide wire for dilatation.The balloon was inflated for one time; however, when the physician changed position for other segment, the balloon did not inflate and became stuck on wire.The device was removed and the procedure was completed with another of the same device.No patient complications were noted and the patient's status was stable.

• 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: 7230764
• MDR Text Key: 98746728
• Report Number: 2134265-2018-00287
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 01/08/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2019
• Device Model Number: H74939148301510
• Device Catalogue Number: 39148-30151
• Device Lot Number: 20622634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• 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 Age: 55 YR
• Patient Weight: 80