MAUDE Adverse Event Report: ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER; SOFT-VU SIZING ANGIOGRAPHIC CATHETER,

Catalog Number	H787107089035
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Complaint # (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2018: during an angiographic procedure, it was noted the catheter tip broke off inside of the patient.The fragment was successfully removed via snare with no harm to the patient.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one soft-vu catheter.A visual examination of the catheter noted that the tip was fractured.The returned device met all manufacturing dimensional specifications.Per the manufacturing engineer for this product family, a review of the complaint sample indicated a fracture of the soft tip close to the weld.Examination of the weld indicated a proper melt and the weld itself did not fail.The catheter was inspected for visual indications of damage that could have led to compromised integrity, revealing surface cracking was evident along portions of the soft tip material.There was also a significant kink in soft tip that may have been caused during recovery of the tip.The distal portion of the soft tip fractured when flexed: this failure mode is consistent with tip embrittlement associated with capa c2013008 and may be related, although the lot number of the complaint sample is not known.The capa implemented a design change on 11-aug-2017 to address the tip fracture failure mode.The packaging lots shipped to this customer in the 6 months prior to the procedure date were reviewed; both pre and post design change product was shipped.The observed occurrence rate is very low with a rate of 6.8 ppm and was adequately addressed during the capa remediation.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The instructions for use, which is supplied to the end user with this catalog number, contains the following statements: potential adverse effects.Emboli.Death.Warnings.Never advance or retract an angiographic catheter or guidewire against resistance.This may result in damage to the vessel, the product, or both.Reshaping of catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat.Do not leave curved tipped catheters straightened over guidewires for extended periods of time.This will result in failure of the catheter tip to re-form to its intended shape.Always use a guidewire to remove the catheter from the vasculature.Failure to do so may result in damage to the vessel, puncture site, product, or all three.When retracting catheters, great care must be taken to avoid exerting excessive pressure at the groin entry site.Excessive pressure may result in damage to the vessel, the catheter, or both.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint (b)(4).

• Brand Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER
• Common Device Name: SOFT-VU SIZING ANGIOGRAPHIC CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 7205175
• Report Number: 1319211-2018-00004
• Device Sequence Number: 11008893
• Product Code: DQO
• UDI-Device Identifier: H787107089035
• UDI-Public: H787107089035
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: H787107089035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 04/16/2018
• 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: Required Intervention