MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ADVANTAGE FIT SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068502110

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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.

Event Description

It was reported to boston scientific corporation that an advantage fit was used during a sling case performed on (b)(4) 2016.According to the complainant, during the procedure and inside the patient, the blue sleeve scrunched up and was retained inside the patient.The incision was enlarged and the physician dissected down to retrieve the plastic sheath and pulled it up with a kelly clamp.The procedure was completed with another advantage fit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Visual analysis of the returned advantage fit device confirmed that the dilator was bunched and with two holes.The delivery device was not returned.The device most likely encountered anatomical or procedural factors which limited its performance, therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution. a search of the complaint database confirmed that no similar complaints exist for the specified batch. the investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.

Event Description

It was reported to boston scientific corporation that an advantage fit was used during a sling case performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the blue sleeve scrunched up and was retained inside the patient.The incision was enlarged and the physician dissected down to retrieve the plastic sheath and pulled it up with a kelly clamp.The procedure was completed with another advantage fit.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5641119
• MDR Text Key: 44736008
• Report Number: 3005099803-2016-01321
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/20/2018
• Device Model Number: M0068502110
• Device Catalogue Number: 850-211
• Device Lot Number: ML00003003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2016
• Initial Date FDA Received: 05/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR