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

Model Number H74939148251210

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: 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: 2134265-2018-00084.It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified posterior tibial artery of the right leg.After 300cm, 8cm poly tip v-18 control wire crossed the lesion, a 2.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilation.However, when the physician started to inflate the balloon at 12 atmospheres, the balloon did not inflate.The physician pulled the device and attempted to inflate the balloon again but was unsuccessful.Subsequently, a kink was noted on the proximal portion of the catheter and the v-18 control wire became stuck in the catheter.The physician then encountered difficulties in removing the guide wire from the balloon catheter.The procedure was completed with another sterling balloon catheter.No patient complications were reported 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 tip is damaged.There are numerous shaft kinks and the shaft is stretched in numerous locations.Functional testing was carried out by attaching an inflation device filled with water to the hub of the device, water leaked from the distal tip.The inner shaft was noticed to have a puncture hole 22mm from the strain relief which is consistent with the damage that is seen caused by use of a guidewire.Functional testing was completed using a thruway.018 guidewire, as the guidewire used in the clinical event was not returned for analysis.The thruway guidewire was inserted distally and could not advance due to the numerous kinks and stretching.Inspection of the remainder of the device presented no other damage or irregularities.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: 2134265-2018-00084.It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified posterior tibial artery of the right leg.After 300cm, 8cm poly tip v-18¿ control wire¿ crossed the lesion, a 2.5mm x 120mm x 150cm sterling¿ sl balloon catheter was advanced for dilation.However, when the physician started to inflate the balloon at 12 atmospheres, the balloon did not inflate.The physician pulled the device and attempted to inflate the balloon again but was unsuccessful.Subsequently, a kink was noted on the proximal portion of the catheter and the v-18¿ control wire¿ became stuck in the catheter.The physician then encountered difficulties in removing the guide wire from the balloon catheter.The procedure was completed with another sterling balloon catheter.No patient complications were reported 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: 7168974
• MDR Text Key: 96606930
• Report Number: 2134265-2017-12895
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2019
• Device Model Number: H74939148251210
• Device Catalogue Number: 39148-25121
• Device Lot Number: 20682291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2017
• 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: 50 YR
• Patient Weight: 85