MAUDE Adverse Event Report: COLOPLAST CORP ALTIS KIT; SURGICAL MESH

Model Number 5196502400

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.

Event Description

According to the available information, the tip of the altis trocar just came off during placement.The physician decided to leave the metal tip behind after confirmation of an x-ray during the case.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation and additional event information.A review of the manufacturing documentation was conducted for part number 5196502400 and lot number 6370123.This review concluded that the product met all specifications prior to shipment.A review of the complaint history database revealed no trends for this same lot number and failure mode.Review of nonconforming reports also revealed no non-conformance's for this lot.No corrective actions are associated with this lot.Product was found to be manufactured to the validated production process and passed each required inspection and physical test.Quality concluded that altis¿ product part number 5196502400 and lot number 6370123 met specification when shipped.Without the benefit of having the introducer returned for evaluation, the cause of the reported failure mode is undetermined.

Event Description

Additional information stated the introducer was used during the procedure but was not returned to coloplast for evaluation.The tm stated that after the introducer tip broke off the physician used the remaining introducer to finish the case.The physician had to position the remaining introducer upside down in order to be able to place the sling properly.The introducers are specific to either right side or left side, but are not intended to be used interchangeably.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis MN 55411
• MDR Report Key: 8434158
• MDR Text Key: 139252004
• Report Number: 2125050-2019-00222
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5196502400
• Device Catalogue Number: 519650
• Device Lot Number: 6370123
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR