MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC

Model Number	72400165
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Balloon: model- 72400024, lot sn- (b)(4), mfg date- 06/02/2008, exp date- 05/22/2013, gtin- (b)(4).Pump: model- 72400098, lot sn- (b)(4), mfg date- 07/08/2008, exp date- 07/03/2013, gtin- (b)(4).Device not returned for evaluation.
Event or Problem Description
It was reported that due to a pierced cuff the patient had his artificial urinary sphincter (aus) removed and replaced.
Additional Manufacturer Narrative
Returned product consisted of an ams800 pressure regulating balloon, occlusive cuff and a control pump.The ams800 occlusive cuff was visually inspected and microscopically examined.The cuff was measured, and the device size was consistent with the reported information.Functional tests concluded there was a pinhole in the cuff shell at a fold causing fluid loss.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The ams800 control pump was visually and microscopically examined.No leaks were found.The pump was not functionally tested due to the confirmed cuff leak.The ams800 pressure regulating balloon was visually and microscopically examined.No leaks were found.Functional tests were not performed due to the confirmed cuff leak.Correction to g1, h2, h3, and h6: updated to include device analysis.Balloon, model- 72400024, lot sn- 548464002, mfg date- 06/02/2008, exp date- 05/22/2013, gtin- (b)(4).Pump: model- 72400098, lot sn- (b)(4), mfg date- 07/08/2008, exp date- 07/03/2013, gtin- (b)(4).
Event or Problem Description
It was reported that due to a pierced cuff the patient had his artificial urinary sphincter (aus) removed and replaced.

• Brand Name: AMS 800 URINARY CONTROL SYSTEM
• Common Device Name: DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9131874
• Report Number: 2183959-2019-66430
• Device Sequence Number: 3070434
• Product Code: EZY
• UDI-Device Identifier: 00878953000763
• UDI-Public: 00878953000763
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2009
• Device Model Number: 72400165
• Device Catalogue Number: 72400165
• Device Lot Number: 397542010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention