MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) FLEXIMA? APDL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number M001271340

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2015

Event Type  No Answer Provided  

Event Description

It was reported the suture broke.During preparations for a drainage procedure a flexima¿ apdl drainage catheter was selected.When the device was unpackaged it was noted the suture was not attached to the pig tail.The device was never introduced to the patient.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the suture broken.Also the metal cannula was received loaded inside the catheter, it was found bent/kink at the distal section, also it has evidence of use (residues).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 the suture broke.During preparations for a drainage procedure a flexima¿ apdl drainage catheter was selected.When the device was unpackaged it was noted the suture was not attached to the pig tail.The device was never introduced to the patient.

• Brand Name: FLEXIMA? APDL
• Type of Device: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4664938
• MDR Text Key: 5623767
• Report Number: 2134265-2015-01909
• Device Sequence Number: 1
• Product Code: FFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2018
• Device Model Number: M001271340
• Device Catalogue Number: 27-134
• Device Lot Number: 17557334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• 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