MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. WALLACE¿ TRIAL TRANSFER CATHETER; CATHETER, ASSISTED REPRODUCTION

Catalog Number	TT1816N
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a wallace¿ trial transfer catheter was "stiffer than usual".A doctor observed that the catheter appeared to cause trauma and a bleeding condition during an in vitro fertilization procedure.No permanent injury was reported.

• Brand Name: WALLACE¿ TRIAL TRANSFER CATHETER
• Common Device Name: CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6711923
• Report Number: 3012307300-2017-01562
• Device Sequence Number: 16496815
• Product Code: MQF
• UDI-Device Identifier: 15019315015663
• UDI-Public: 15019315015663
• Combination Product (Y/N): N
• Initial Reporter Country: CE
• PMA/510(K) Number: K990348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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: Physician
• Device Expiration Date: 03/28/2022
• Device Catalogue Number: TT1816N
• Device Lot Number: 2949739
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other