MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER RX7MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51007004L

Device Problem Structural Problem (2506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information to include from section e facility name: tango central hospital, a public interest incorporated foundation concomitant device: unk sheath (6gf), unk stent. (b)(6). This device was received for analysis, but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the doctor pointed out that the position of the balloon marker of 7mm x 4cm 155 saber rapid exchange (rx) percutaneous transluminal angioplasty (pta) balloon catheter might be out of alignment. It seems that the markers on the proximal side are placed within the interval of 4 cm. The length of the balloon shoulder on the distal side and the length of the shoulder on the proximal side appear to be clearly different. They commented that the position of the marker may have shifted at the product manufacturing stage. There was no reported patient injury. The lesion was from the right common iliac artery to superficial femoral artery with occlusion. An unknown 6gf sheath was inserted from the left brachial and inserted to the right iliac artery. After an unknown stent was implanted at the right superficial femoral artery, a saber pta was used to the right common iliac artery with moderate calcification and tortuosity and stenosed. The device was opened in sterile filed. There were no difficulty noted in the balloon during prep. There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel. There was no difficulty crossing the lesion. The catheter has never been in an acute bend. The product removed intact (in one piece) from the patient. The device will be returned for evaluation. No other information was provided.

• Brand Name: SABER RX7MM4CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer (Section G): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• Manufacturer Contact: karla castro ; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000 ; 7863138372
• MDR Report Key: 11298293
• MDR Text Key: 230949658
• Report Number: 9616099-2021-04245
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 51007004L
• Device Catalogue Number: 51007004L
• Device Lot Number: 82187027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial