MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH PINNACLE PELVIC FLOOR REPAIR KITS; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Model Number UNK558

Device Problem Material Deformation (2976)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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 a pinnacle pelvic floor repair kits was used during a pelvic floor procedure.According to the complainant, post procedure, the patient experienced chronic pain and requested removal of the device.Reportedly, the device had been correctly situated, but the anterior mesh was contracted.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

Upon review, the upn of the complaint device is actually unknown.However, it was reported to be a pinnacle mesh.

Event Description

It was reported to boston scientific corporation that a pinnacle pelvic floor repair kit was used during a pelvic floor procedure.According to the complainant, post procedure, the patient experienced chronic pain and requested removal of the device.Reportedly, the device had been correctly situated, but the anterior mesh was contracted.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

• Brand Name: PINNACLE PELVIC FLOOR REPAIR KITS
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• 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: 6303223
• MDR Text Key: 66555294
• Report Number: 3005099803-2017-00201
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K071957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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