MAUDE Adverse Event Report: COLOPLAST A/S ALTIS KIT; SURGICAL MESH

Model Number 5196501022

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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.Should additional facts prompt us to alter or supplement any information of 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, dr.Encountered a problem when implanting an altis mesh.Indeed, the tip of one of the introduction device was broken during the anchoring of the mesh.The tip remained in the patient's body.Need to open a 2nd set for implantation of the mesh.Assitional information received indicated the tip is still in patient, surgeon found it touchy to remove.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned device: one left introducer was received for evaluation.Most the introducer tip was missing.The base of the tip showed signs of significant bending prior to breaking.No further anomalies were noted.According to the available information, the tip of one of the introducers was broken during the anchoring of the altis mesh.The tip remains in the patient's body.Quality's observations are consistent with the reported event.The instructions for use instructs users to keep the introducer against the patient's body and parallel with the ipsilateral ischiopubic ramus when advancing the anchor through the obturator membrane.If the introducer is not parallel with the ramus, the tip of the introducer may contact the bone and cause breakage of the tip of the introducer.Therefore, quality concludes that the root cause of the event is user error due to the introducer not being held parallel to the ramus during implantation of the anchor.This complaint was forwarded to the contract manufacturer (cm) for review.The cm reviewed the manufacturing 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.Management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type are captured in the product risk documentation.Based on this information, and because the device is not available for evaluation, no further corrective action is required at this time.

• Brand Name: ALTIS KIT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: stephanie perryman ; 1601 west river road north; minneapolis, MN 55411 ; 6123024983
• MDR Report Key: 7165573
• MDR Text Key: 96443000
• Report Number: 2125050-2018-00004
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: P000006
• 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: 02/19/2018

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: Physician
• Device Model Number: 5196501022
• Device Catalogue Number: 5196501022
• Device Lot Number: 5559448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/13/2017
• Supplement Dates FDA Received: 02/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other