MAUDE Adverse Event Report: COLOPLAST CORP ALTIS; SURGICAL MESH

Model Number 5196501022

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming reports and capa review.No trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the thin, distal portion of the left introducer broke during the passage of the obturator membrane.A metallic part remained in the patient.

Manufacturer Narrative

This follow-up mdr is created to document the conclusion of the investigation.No components were received for evaluation.Without the benefit of analyzing the components, quality cannot confirm any observations or comment on the condition of the product.If the components become available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the complaint history database revealed no trends for this lot.Review of nonconforming reports revealed no nonconformance's for this lot.No capas are associated with this lot.No patient injury was reported.Cm reviewed records for this device and confirmed that there were no discrepancies that would have contributed to this complaint and verified that the devices from this lot met all specifications prior to release.

Manufacturer Narrative

This follow-up was created to document the returned device and conclusion of the investigation.An altis sling and two introducers were received for evaluation.Microscopic examination revealed the tip of one introducer was detached.There was dark unknown residue on both introducer handles.The sling was received fully intact.No abnormalities were noted with the sling or other introducer.Based on the information received, the left introducer tip broke during the passage of the obturator membrane.As quality cannot comment on the surgical procedure, quality can confirm that a significant force is needed to detach/break the introducer tip.As the introducers passed all manufacturing specifications during production, quality is unable to confirm the reason for the tip breakage.

• Brand Name: ALTIS
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST CORP; 1601 west rivier road north; minneapolis, MN 55411
• MDR Report Key: 9142148
• MDR Text Key: 160788756
• Report Number: 2125050-2019-00833
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 5196501022
• Device Catalogue Number: 519650
• Device Lot Number: 6571036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 09/02/2019; 09/02/2019
• Supplement Dates FDA Received: 11/08/2019; 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other