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

Model Number 5196502400

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

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 12/06/2017

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, broken introducer tip.Additional information received from the tm [territory manager] indicated while the doctor was inserting the static anchor, the doctor said he felt bone.The tm instructed him to apply pressure to the helical portion of the introducer.Upon this instruction, the doctor applied pressure.The doctor said he still felt bone and then when trying to reposition the introducer he tried to insert the anchor once more.He pulled the introducer from the vaginal incision and realized the tip of the introducer was missing.The doctor tried to find the missing piece and was unsuccessful.The doctor then decided to try a second sling system and was successful.

Manufacturer Narrative

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.The full cm response is attached to the complaint.The device is not available for evaluation.Without the benefit of analyzing the explant, quality cannot confirm any observations and cannot comment on the condition of the prosthesis.Based on the available information, the most likely root cause of the event can be attributed to user error during implantation of the static anchor.If the explanted device becomes available, or additional information is received, quality will re-evaluate this complaint in accordance to procedures.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 KITALTIS 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: sarah o'gara ; 1601 west rivier road north; minneapolis, MN 55411 ; 6123578517
• MDR Report Key: 7165574
• MDR Text Key: 96444191
• Report Number: 2125050-2018-00003
• 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,other
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

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: 5196502400
• Device Catalogue Number: 5196502400
• Device Lot Number: 5449719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 05/03/2018
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR