MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM

Catalog Number DP-40K

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the device would not cut completely through the vessel and it was difficult to remove.The aorta was torn during removal and required repair with stitches.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).One sample of code dp-40k from batch 74m1400404 was received, sample shows residues of blood and its original packaging is missing.A blade and core dimensional verification was performed reflecting acceptable results in all measures, consult forms (b)(4).Functionality of sample was reviewed; unit demonstrated acceptable results since return without obstructions, consults results in form (b)(4).No dents were found it in metallic parts and no other type of damage in piece.No corrective actions will be implemented due the sample received met the functional specifications established in the manufacturing plant.Customer complaint cannot be confirmed based on the functional results obtained on the sample returned for evaluation.Unit demonstrated to be within specification due the results obtained in test "return without obstructions" that were acceptable.

Event Description

Alleged event: the device would not cut completely through the vessel and it was difficult to remove.The aorta was torn during removal and required repair with stitches.The patient's condition was reported as fine.

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4964089
• MDR Text Key: 23401688
• Report Number: 3004365956-2015-00192
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: DP-40K
• Device Lot Number: 74M1400404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention