MAUDE Adverse Event Report: ANGIODYNAMICS DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	10302804
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue with several duramax catheters.Per the user, they have recently had eight incidents of broken clamps of permacath catheters.All incidents occurred with the same scenario.The clamps were broken outside the patients resulting in the catheter having to be removed and replaced.The patients did not experience any adverse effects or harm due to these incidences.
Additional Manufacturer Narrative
It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).For each of the 8 occurrences, reference: (b)(4).
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of broken clamp cannot be confirmed.No sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A possible root cause for the clamps breaking could be due to handling damage during use.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use, which is supplied to the end user with this catalog number states: "catheter will be damaged if clamps other than what is provided with this kit are used.Irrigate catheter with saline, then clamp catheter extensions to assure that saline is not inadvertently drained from lumens.Use clamps provided.Caution: do not clamp the dual lumen portion of the catheter.Clamp only the extensions.Do not use serrated forceps, use only the in-line clamps provided.Attach syringes to both extensions and open clamps.Blood should aspirate easily from both arterial and venous sides.If either side exhibits excessive resistance to blood aspiration, the catheter may need to be rotated or repositioned to obtain adequate blood flows.Once adequate aspiration has been achieved, both lumens should be irrigated with saline filled syringes using quick bolus technique.Assure that extension clamps are open during irrigation procedure.Close the extension clamps, remove the syringes, and place an injection cap on each luer lock connector.Avoid air embolism by keeping extension tubing clamped at all times when not in use and by aspirating then irrigating the catheter with saline prior to each use.With each change in tubing connections, purge air from the catheter and all connecting tubing and caps.Once the catheter is locked with heparin, close the clamps and install injection caps onto the extensions' female luers.Caution: extension clamps should only be open for aspiration, flushing, and dialysis treatment." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).For each of the 8 occurrences, reference: (b)(4), 1317056-2023-00047.(b)(4), 1319211-2023-00025.(b)(4), 1319211-2023-00026.(b)(4), 1319211-2023-00027.(b)(4), 1319211-2023-00028.(b)(4), 1319211-2023-00029.(b)(4), 1319211-2023-00030.(b)(4), 1319211-2023-00031.

• Brand Name: DURAMAX 2 CHRONIC HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16771259
• Report Number: 1319211-2023-00031
• Device Sequence Number: 3139753
• Product Code: MSD
• UDI-Device Identifier: H787103028045
• UDI-Public: H787103028045
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K101843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10302804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown