MAUDE Adverse Event Report: AV MEDICAL TECHNOLOGIES CHAMELEON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	CH10-40-75US
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the balloon was being used to treat a central stenosis, the balloon was indicated for a rated burst pressure of 14atm, but the physician said that on the second angioplasty the balloon ruptured at 10atm.Nothing unusual observed on the device prior to use, no damage on the box or packaging, all pieces were retrieved in the patients body, fluoroscopy was done to confirm all pieces were retrieved, introducer sheath was used to allow the balloon to be introduced, no treatment/intervention was required as a result of balloon burst, there was no harm to the patient due to the rupture.They switched out balloons to complete the procedure (angioplasty).

• Brand Name: CHAMELEON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): AV MEDICAL TECHNOLOGIES; 21 habarzel street; tel-aviv 67770 16; IL 6777016
• MDR Report Key: 10124043
• Report Number: 3011144059-2020-00003
• Device Sequence Number: 19732928
• Product Code: LIT
• UDI-Device Identifier: 07290016745061
• UDI-Public: 07290016745061
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2020

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 Model Number: CH10-40-75US
• Device Catalogue Number: CH10-40-75US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1