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

Model Number H74939032404080

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2015

Event Type  malfunction  

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 balloon deflation issues occurred.The stenosed target lesion was located in a "quite" tortuous 4mm artery below the knee.A 4.0mmx40mmx80cm 4fr sterlin balloon catheter was advanced for dilatation.An inflation syringe was used to inflate the balloon to its rated burst pressure and was then deflated.However, during deflation, it was noted that the balloon could only deflate partially despite negative pressure on the inflation syringe.The balloon was able to be successfully removed the device through the sheath despite the partial deflation.The procedure was completed with this device.No harm to the patient was reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: retuned product consisted of a sterling balloon catheter with blood in the lumen.An inflation device filled with water was used to inflate the device to rated burst pressure (rbp).Device inflated within 15 seconds and held pressure for 5 minutes.Negative pressure was applied to the device, but the device would not deflate.Microscopic inspection of the markerband found no evidence of damage or irregularities.Microscopic inspection on the tip found no irregularities or damage.During inflation, it was noticed that the outer shaft was damaged (stretched) 31 cm from the strain relief, for 12mm.There was a kink in both the inner and outer shafts, in the area where the shaft was stretched (32 cm from the strain relief).Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.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 balloon deflation issues occurred.The stenosed target lesion was located in a "quite" tortuous 4mm artery below the knee.A 4.0mmx40mmx80cm 4fr sterling¿ balloon catheter was advanced for dilatation.An inflation syringe was used to inflate the balloon to its rated burst pressure and was then deflated.However, during deflation, it was noted that the balloon could only deflate partially despite negative pressure on the inflation syringe.The balloon was able to be successfully removed the device through the sheath despite the partial deflation.The procedure was completed with this device.No harm to the patient was reported and the patient's status was stable.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 5320381
• MDR Text Key: 34199264
• Report Number: 2134265-2015-08985
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K053116
• 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: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: H74939032404080
• Device Catalogue Number: 39032-40408
• Device Lot Number: 18109544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2015
• 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