MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Model Number	45887
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
A distributor reported an issue with a bio-stable 5f dl-55cm ir-145 kit non-valved with nitinol gw pg.A few months after placement, while the nurse was flushing the device prior to chemotherapy, it was noted to be leaking.After consultation with a physician, the decision was made to remove the picc.It was examined and the leak was found to be originating from the 10cm marking.The picc was removed and replaced.The patient's chemotherapy treatment was temporarily postponed until the replacement picc was placed.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.The reported device is not available to be returned to the manufacturer for evaluation at this time.
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned for evaluation was a dual lumen 5f bioflo picc.As received, the 5f bioflo catheter contained bio matter inside and outside.No defects were noted.The full length of the catheter was visually inspected and no holes were noted.The 5f dl catheter was primed and then clamped at the distal end and pressure was applied by hand, and no leaks were noted/.The catheter functioned as intended.The customer's complaint description of the leak at the 10cm mark could not be confirmed during sample review.No holes observed in the catheter tubing and no leaks observed during testing.No manufacturing non-conformances were observed during sample evaluation.The root cause for the leak observed by the customer cannot be determined.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: as noted during the review of the directions for use (dfu) that is supplied in the reported kit, the following precautions/warnings are stated: warnings: do not use if package is opened or damaged.Do not fully insert catheter up to suture wing.Do not use sharp objects to open package as damage to the device may occur.If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.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).
Additional Manufacturer Narrative
Per request of the reporter, the complaint file was repopened and complaint sample was re-examined.Initial evaluation of picc catheter tubing stated that there was no hole/leak in the catheter tubing.Customer reported testing it themselves before sending to us and they did observed a hole in the catheter tubing.Returned for evaluation was a dual lumen 5f bioflo picc.As received, the 5f bioflo catheter contained bio matter inside and outside.A hole in the catheter tubing was observed around the 10cm mark as indicated in the event description.Functional testing of the catheter confirmed a hole as leaking was noted.The customer's complaint description of catheter leak at the 10cm mark was confirmed during sample review.A definitive root cause for the slice/hole in the catheter tubing could not be determined based on the sample review, however, over-pressurization is potential.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: as noted during the review of the directions for use (dfu) that is supplied in the reported kit, the following precautions/warnings are stated: warnings: · do not use if package is opened or damaged.· do not fully insert catheter up to suture wing.· do not use sharp objects to open package as damage to the device may occur.· if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.· do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair: in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.Potential complications/adverse events: catheter rupture.Extravasation of infusate management of lumen occlusion: provided there is no resistance with aspiration, flush the catheter vigorously with sterile normal saline to try to move the tip away from the vessel wall.Use a 10 ml or larger syringe.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis.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).

• Brand Name: BIOFLO PICC WITH ENDEXO TECHNOLOGY
• Common Device Name: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12539345
• Report Number: 1317056-2021-00171
• Device Sequence Number: 20123575
• Product Code: LJS
• UDI-Device Identifier: H965458870
• UDI-Public: H965458870
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/10/2021

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 Expiration Date: 07/31/2022
• Device Model Number: 45887
• Device Catalogue Number: 45887
• Device Lot Number: 5630390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/19/2021; 11/11/2021; 12/10/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/20/2021; 11/11/2021; 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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 Age: 4 YR
• Patient Sex: Male