MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPSYLON Y MESH KIT; GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES

Model Number M0068318220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

The event date was approximated to (b)(6) 2019, the date the complaint was first reported to bsc, as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was implanted during a sacrocolpopexy procedure.According to the complainant, the patient presented an obstruction in the small intestine post-procedure.Reportedly, this was addressed by drainage tubing.The patient's current condition is reported to be good.

Manufacturer Narrative

Block b3: the event date was approximated to (b)(6) 2019, the date the complaint was first reported to bsc, as no event date was reported.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Blocks f10 and h6: patient codes of 2422 and 3191 capture the reportable events of obstruction in the small intestine and drainage tubing respectively.Block h6: conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device is implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: block b5 updated.

Event Description

It was reported to boston scientific corporation that an upsylon y-mesh was implanted during a sacrocolpopexy procedure.According to the complainant, the patient was diagnosed with small intestine obstruction after the procedure and the physician believed that the upsylon had caused it.Reportedly, this was addressed by drainage tubing.The patient's current condition is reported to be good.

• Brand Name: UPSYLON Y MESH KIT
• Type of Device: GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8978334
• MDR Text Key: 157041246
• Report Number: 3005099803-2019-04384
• Device Sequence Number: 1
• Product Code: OHD
• UDI-Device Identifier: 08714729848103
• UDI-Public: 08714729848103
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068318220
• Device Catalogue Number: 72912
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention